Impact of Food Supplementation on Quality of Life in Patients With Endometriosis and Pelvic Pain.
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Food supplement (T1675), Placebo.
- Кому может быть актуально
- Состояния в реестре: Endometriosis (Diagnosis). Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Experimental Study of Quality of Life in Patients With Endometriosis and Pelvic Pain Treated With Doliral Dietary Supplementation Versus Placebo.
Обзор
This study examines whether the food supplement Doliral can improve quality of life and reduce pelvic pain in women with endometriosis, compared with placebo, over several weeks.
Подробное описание
Patients included into the study will be randomized into two treatment groups (30:30 patients). 30 patients will be treated with the food supplement and 30 patients will be treated with placebo. Both groups will be stratified by the presence or absence of hormonal therapy. Patients will be required to attend 6 study visits (selection visit, baseline or visit 0, and visits 1, 2, 3 and final or visit 4). Patients will complete a daily endometriosis symptom diary, which also includes a record of anti-inflammatory and paing medication use. Study treatment will be administred at Visit 0 or Baseline until Visit 4 or Final. At the study visits, patients will be requested to confirm the pain intensity through the VAS scale for different endometriosis pain types. They will be also requested to complete several questionnaires about quality of life.
Вмешательства
- Пищевая добавка Food supplement (T1675)
Doliral is the food supplement, which is the investigational product at this study. - Другое Placebo
Placebo is the control treatment.
Первичные конечные точки
- To measure the improvement of the quality of life. [Срок оценки: From baseline visit to the final visit at 12 weeks.]
- To measure the improvement of the quality of life. [Срок оценки: From baseline visit to the final visit at 12 weeks.]
- To measure the improvement of the quality of life. [Срок оценки: From baseline visit to the final visit at 12 weeks.]
- To measure the improvement in pain intensity. [Срок оценки: From baseline visit to the final visit at 12 weeks.]
Вторичные конечные точки (2)
- Compare the reduction in the need for prescription and dosage of anti-inflammatory and analgesic pharmacological treatment. [Срок оценки: From baseline visit to the final visit at 12 weeks.]
- To measure the incidence of clinically relevant episodes [Срок оценки: From Visit 1 (2 weeks) to Visit 4 or Final (12 weeks).]
Критерии участия
Критерии включения
- Women of reproductive age with diagnosed endometriosis stage I, II, or III, according to the American Society for Reproductive Medicine (ASRM) classification.
- Women with a diagnosis of endometriosis confirmed by laparoscopy or, in the absence of laparoscopy, by magnetic resonance imaging (MRI) and/or ultrasound.
- Presence of pelvic pain (VAS > 4) during the last three months.
- No indication for surgical intervention at the time of inclusion in the study.
- Patients who are able to provide informed consent.
Критерии исключения
- Patients under 18 years of age.
- Use of analgesic or anti-inflammatory pharmacological treatment, except for ibuprofen at doses up to 600 mg/day or naproxen at doses up to 500 mg/day.
- Surgery within the year prior to inclusion, performed for therapeutic purposes related to the pathology under study.
- Initiation or discontinuation of hormone therapy within the three months prior to inclusion in the study.
- Patients with known allergy or hypersensitivity to Doliral®.
- Pregnant or breastfeeding patients.
- Patients on sick leave: > 1 year, or With no intention of returning to work, or Undergoing a disability or permanent incapacity assessment process.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Испания · 1 центр
- Hospital Clínic de Barcelona — Barcelona
Идентификаторы
NCT: NCT07393958 · ARA-EXP/DOL-2025-01